Identity
- Trade Name
- Maestro FDA UDI
- Generic Name
- Electrosurgical return electrode, single-use FDA UDI
- Device Name
- Neutral Electrode FDA UDI
- Model / Reference
- 1291H FDA UDI
- Description
- Neutral Electrode FDA UDI
Identifiers
- Catalog Number
- M004N0011 FDA UDI
- Primary DI / UDI-DI
- 15060441919998 FDA UDI
- 510(k) Number
- K203494 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical return electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrosurgical return electrode, single-use
Maestro by Nissha Medical Technologies Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K203494 also covers:
- Stryker — NISSHA MEDICAL TECHNOLOGIES SAS
- Swaroplate — NISSHA MEDICAL TECHNOLOGIES SAS
- Swaroplate — NISSHA MEDICAL TECHNOLOGIES SAS
- Swaroplate — NISSHA MEDICAL TECHNOLOGIES SAS
- Swaroplate — NISSHA MEDICAL TECHNOLOGIES SAS
- Swaroplate — NISSHA MEDICAL TECHNOLOGIES SAS
- Swaroplate — NISSHA MEDICAL TECHNOLOGIES SAS
- Swaroplate — NISSHA MEDICAL TECHNOLOGIES SAS
- Swaroplate — NISSHA MEDICAL TECHNOLOGIES SAS
- Swaroplate — NISSHA MEDICAL TECHNOLOGIES SAS
- Swaroplate — NISSHA MEDICAL TECHNOLOGIES SAS
- Swaroplate — NISSHA MEDICAL TECHNOLOGIES SAS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nissha Medical Technologies Sas
Sources (1)
- FDA UDI 24e15c56-dddd-434e-8d67-d143fc780ef2 35 fields · synced May 29, 2026